Posted by Michael Wonder on 09 Oct 2016
Coherus Biosciences announces FDA acceptance of 351(K) biologics license application to U.S. FDA for CHS-1701 (pegfilgrastim biosimilar candidate)
6 October 2016 - Coherus BioSciences today announced that the U.S. FDA has accepted the filing of 351(k) biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate.
The submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is 9 June 2017.
